Titan ES2922Recalls & reported problems
Coloplast A/S · Titan® Touch Scrotal Zero Degree Angle Cylinder Set with Pump · Class 3 · Implant
All models of Titan (62)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Coloplast Titan Touch penile implant has 761 reports, with 1 death and 689 injuries. Many reports describe the implant being removed and replaced after infection, erosion, or breaks in the tubing, and some mention leaks. A recall that started in March 2023 is open, and it concerns pumps with thinner walls than standard, which could fail earlier than expected.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 758
- Deaths reported
- 1
- Injuries reported
- 686
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 758 adverse event reports that list this exact device (DI 05708932539203), received between Mar 24, 2016 and Jul 8, 2026 — classified as 1 death, 686 injuries, 71 malfunctions.
The most frequently reported specific device problem is “Fracture” (174 reports).
1 FDA recall record name this device's identifier, 1 still open.
17 other recalls cover devices cleared under the same FDA submission (P000006); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- Mar 1, 2023Open, Classified
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
Z-1371-2023 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fracture174
- Adverse Event Without Identified Device or Use Problem94
- Insufficient Device Problem Information89
- Fluid/Blood Leak72
- Inflation Problem67
- Pumping Problem43
- Break39
- Inadequacy of Device Shape and/or Size30
Patient problems
- No Clinical Signs, Symptoms or Conditions433
- No Information83
- Unspecified Infection76
- Erosion51
- Pain27
- Failure of Implant21
- No Known Impact Or Consequence To Patient14
- Bacterial Infection13
Recent adverse event reports
The 25 most recent of 758 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 25749153 ↗InjuryJul 8, 2026Material Puncture/Hole
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A CYLINDER PUNCTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25748580 ↗InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO EROSION.
Patient problems: Erosion
MAUDE report 25747570 ↗InjuryJul 6, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO TUBING FRACTURE FROM LEFT CYLINDER TO PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25719937 ↗InjuryJun 18, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH DUE TO A SIZING ISSUE AND THE PATIENT WANTING A NEW DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25551547 ↗InjuryJun 9, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A TUBING FRACTURE FROM PUMP TO TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25447971 ↗InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH A GENESIS DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 25379194 ↗InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT HAD A REAR TIP SLING FROM A PREVIOUS INFLATABLE PENILE PROSTHESIS. THE REAR TIP SLING FAILED, AND THE PATIENT'S CYLINDER ERODED PROXIMALLY. THE PHYSICIAN REMOVED THE RIGHT CYLINDER, INSERTED A TRULOCK PLUG, AND KEPT LEFT CYLINDER.
Patient problems: Erosion
MAUDE report 25244137 ↗InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, DURING IMPLANT SURGERY THE SURGEON CUT THE RIGHT CYLINDER AND PLUGGED, IMPLANTING ONLY THE LEFT CYLINDER DUE TO A PARTIAL PERFORATION IN THE RIGHT CORPORA.
Patient problems: Perforation
MAUDE report 25242121 ↗InjuryMay 19, 2026Fracture
ACCORDING TO THE AVAILABLE, IMPLANT WAS REMOVED AND REPLACED DUE TO TUBING BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25216797 ↗InjuryMay 18, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO INCORRECT SIZING (TOO LONG).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25210544 ↗InjuryMay 11, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A TUBING BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25143398 ↗InjuryMay 1, 2026Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED DUE TO AN UNSPECIFIED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25057369 ↗InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT WAS REMOVED AND REPLACED WITH A GENESIS DUE TO PAIN AND APPARENT INFECTION. UPON EXPLANT, NO INFECTION WAS NOTED.
Patient problems: Pain
MAUDE report 25055910 ↗InjuryApr 28, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A CRACK [FRACTURE] IN THE TUBING BY THE PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25020517 ↗InjuryApr 24, 2026Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A TUBING LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24985309 ↗InjuryApr 23, 2026Physical Resistance/Sticking
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A STIFF PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24966822 ↗InjuryApr 22, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED DUE TO THE RIGHT AND LEFT CYLINDER TUBING FRACTURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955426 ↗InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24945598 ↗InjuryApr 20, 2026Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24927742 ↗MalfunctionApr 20, 2026Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, THERE IS A LEAK IN THE DEVICE, AND ALL THE FLUID HAS LEAKED OUT. A REVISION SURGERY IS PLANNED BUT HAS NOT YET BEEN PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24926639 ↗InjuryApr 20, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION THE IMPLANT WAS REMOVED AND REPLACED DUE TO MALFUNCTION. TEAR IN PUMP TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24925076 ↗InjuryApr 17, 2026Pumping Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANTED PUMP WAS REMOVED AND REPLACED DUE TO A PUMP MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24916490 ↗InjuryApr 17, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO POTENTIAL DISTAL EROSION. REIMPLANTED A NEW SMALLER 20 CM CYLINDER AND CONNECTED TO THE EXISTING RESERVOIR.
Patient problems: Erosion
MAUDE report 24915471 ↗InjuryApr 17, 2026Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO AN UNSPECIFIED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912636 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P000006. One submission often covers many models, so check the product and lot details in each record.
- Z-1361-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
- Z-1370-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
- Z-1374-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
- Z-1366-2023 · Mar 1, 2023 · Open, ClassifiedTitan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
- Z-1363-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
- Z-1367-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
- Z-1364-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
- Z-1373-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
- Z-1372-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
- Z-1365-2023 · Mar 1, 2023 · Open, ClassifiedTitan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
- Z-1359-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
- Z-1369-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
- Z-1362-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
- Z-1360-2023 · Mar 1, 2023 · Open, ClassifiedTitan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
- Z-1375-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
…and 2 more.
Other Device, Impotence, Mechanical/Hydraulic devices
- Titan ES2920Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall862 reports
- Titan ES2918Coloplast A/S · Device, Impotence, Mechanical/Hydraulic577 reports
- Titan ES8920Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall476 reports
- Titan ES8922Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall334 reports
- Titan 517750Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall258 reports
- Titan ES8918Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall225 reports
- Titan ES2818Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall222 reports
- Titan ES8820Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall192 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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